Cleared Traditional

K082728 - VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM

K082728 is an FDA 510(k) clearance for VERTEX RECONTRUCTION SYSTEM, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K082728 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Jan 2009
Decision
120d
Days
Class 2
Risk

K082728 is an FDA 510(k) clearance for the VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on January 16, 2009 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K082728

510(k) Number K082728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2008
Decision Date January 16, 2009
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 382
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K082728.
SYNTHES SYNAPSE TRANSCONNECTOR
K090549 · Synthes Spine · May 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K090714 · Medtronic Sofamor Danek · Apr 2009
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
K090252 · Lanx, Inc. · Mar 2009
MESA AND RANGE SPINAL SYSTEMS
K082769 · K2m, Inc. · Dec 2008
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K081906 · Globus Medical, Inc. · Nov 2008
VERTEX RECONSTRUCTION SYSTEM
K083071 · Medtronic Sofamor Danek · Nov 2008